Job Description

To co-ordinate the total Large Volume Parenteral filling production operation from a pharmaceutical perspective.



Duties:



Is conversant and well versed with daily production program.



Identifies and addresses daily pharmaceutical problems.



Reports / liaises daily with the Department Manager on the pharmaceutical (production) situation.



Performs department pharmacy duties.



Assist the Production Leaders to ensure that all staff is properly trained for their job.



Writes, reviews up-dates department Standard Operating Procedures and Good Manufacturing Practices.



To support production department in ensuring that the daily production program and targets are met.



Responsible for the department compliance with factory rules and regulations.



Responsible for the maintenance of Good Manufacturing Practices Standards within the department.



Responsible for the accurate completion and reconciliation of departmental batch book documents.



Assist the Department Manager with the close out of Deviations, CAPA's audit findings etc.



Responsible for the implementation of change controls.



Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack.



Will be required to stand in for Production Leaders in the event of training or absenteeism etc.



Supervision and training of pharmaceutical staff.



From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent.



Competence Requirements:


Understand LVP production processes GMP Principles Understand quality investigation requirements (risk assessments, deviations, change controls ie. Kabitrack) Risk evaluation and documentation Interpret and apply production plan Batch book documentation and auditing requirements Logbook and area compliance Root Cause Analysis Health and Safety compliance

Understand process for entering Grade C and D areas




B Pharm Tertiary qualification. Registered Pharmacist with South African Pharmacy Council. Pharmaceutical manufacturing experience. Proven 'hands - on' managerial ability Production management skills Specific Large Volume Parenteral process technical skills Human resources / industrial relations skills N.O.S.A and MOSACT awareness * 1 year experience minimum